Patients overwhelmingly support disclosure and apology in unanticipated medical outcomes. A better understanding of an effective disclosure process, the impact of disclosure on patient satisfaction, and the legal implications of disclosure are needed. Moreover, little information exists on successful implementation of disclosure policies across large health systems. Objective: We propose a prospective study of disclosure of unanticipated medical outcomes by physicians within a large, regional health care system. The goals of this study are to both implement and to evaluate a system-wide evidence-based, ethical, and legally sound policy on disclosures of unanticipated medical outcomes. This proposal has three Specific Aims: 1) To validate and implement a protocol outlining the process of disclosure across all the hospitals within the system;2) To prospectively measure the satisfaction of patients and their families with disclosure, as well as physician satisfaction, and it's effect on patient safety;3) To explore the relationship between malpractice claims filed ("actual" and "potential") with other variables including: patient/family satisfaction;disclosure occurred;patient and physician demographics;severity of harm, presence of error;and concordance between patient/family and physician views of the disclosure. Methods: Our healthcare system is uniquely comprised of a well-integrated combination of two governing entities, University of Utah Health Care and Intermountain Healthcare, with a long history of collaboration, and includes forty hospitals, specialty centers and clinics. We will use the results of a pilot study already underway to determine how physicians and the families of patients communicate during a disclosure conversation. We will then use a family focus group to assess the face validity of the disclosure process, and a Risk Manager Focus group to assess the content validity. Once validated, the Protocol for Disclosure of Unanticipated Medical Events will be pilot-tested in actual disclosure proceedings. Risk Management personnel across the region will then participate in an intensive educational intervention: regional conference presentation;webcast sessions and site visits to statewide regional hospitals;ongoing self-paced web-learning;and web-based refresher courses. We will then use a prospectively assembled, case-control design of a population-based cohort of patients to determine the effect of our intervention on patient satisfaction following the disclosure. Finally, we will use the data assembled, and followed longitudinally, to build a generalized, mixed-effect model simulating the relationship between disclosure variables and subsequent medico-legal activity. Implications and Impact: This proposal represents the first known attempt to establish an evidence-based, standardized protocol for the disclosure unanticipated medical outcomes across a geographical region of the United States. Two large healthcare entities will be joined in this ambitious research effort. This study could improve patient satisfaction and may help to reduce the burden of subsequent medical lawsuits. PUBLIC HEALTH RELEVANCE: Implementation of an evidence-based, standardized protocol for the disclosure unanticipated medical outcomes across a geographical region of the United States could improve patient satisfaction and may help to reduce the burden of subsequent medical lawsuits.